NIH GUIDE, Volume 23, Number 40, November 18, 1994


P.T. 34



  Viral Studies (Virology) 

  Clinical Trial 

National Cancer Institute

The National Cancer Institute, Division of Cancer Prevention and

Control, is soliciting proposals for an HPV Quality Control (QC)

Group that will be responsible for overseeing all aspects of HPV DNA

testing for a randomized clinical trial among 3,600 women with the

cervical cytologic diagnoses of "atypical squamous cells of

undetermined significance" (ASCUS) and 3,600 women with "low-grade

squamous intra-epithelial lesions" (LSIL).  The HPV QC Group shall be

responsible for maintaining the quality of the trial's HPV DNA

testing.  The general requirements include: (1) preparation with the

other collaborators of the final protocols, data systems, and study

forms; specifically, identifying the optimal means to collect, store,

and transport cervical specimens for HPV DNA testing; (2) prior to

enrollment, choosing optimal HPV DNA testing methods, assessing the

qualifications of testing laboratories, preparing a list of approved

laboratories, and validating the performance of participating

laboratories before enrollment; (3) during the conduct of the trial,

monitoring and optimizing all aspects of the Trial procedures manual

related to HPV DNA testing including the design and conduct of masked

quality control experiments and the performance of repeat "in-house

testing of specimens; (4) ongoing participation in the overall

supervision of the Trial via the Steering Committee and its

subcommittees; (5) cooperation with all trial administrative

functions, including reporting, data management, and proper handling

of trial-related biospecimens; and (6) establishment of Data

Management and Quality Assurance systems.


Requests for this solicitation must be in writing and reference the

RFP Number, NCI-CN-55044-07.  The RFP is tentatively scheduled for

release on December 1, 1994 with proposals due approximately January

30, 1995.  No collect calls will be accepted.  Requests should be

mailed to:

Victor S. Buyny

Research Contracts Branch, PCCS

National Cancer Institute

Executive Plaza South, Room 635

6120 Executive Boulevard, MSC 7226

Bethesda, MD  20892-7226

Telephone:  (301) 496-8603


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